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Is 3D Modeling From Non-contrast CT Accurate for Minimally Invasive Lung Segmentectomies ? (3D-LS)

U

University Hospital, Strasbourg, France

Status

Not yet enrolling

Conditions

Lung Cancer
Non-Small Cell Lung Cancer

Treatments

Diagnostic Test: Thoraco-abdomino-pelvic CT scan without and with contrast injection.

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

To assess the RELIABILITY in terms of accuracy of 3D-CT and 2D-CT reconstructions compared to intraoperative data regarding bronchovascular anatomy and tumor location. 3D CT reconstruction (CT scan without contrast injection) with Innersight3D® is equivalent to 2D CT (CT scan with contrast injection) for planning a minimally invasive lung segmentectomy.

Evaluate the impact of 3D reconstruction (from a CT scan without injection of contrast agent) on intraoperative and postoperative results

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patient ≥ 18 years
  • Patient agreeing to participate in the study
  • Patient with clinical stage IA lung lesions ≤ 2 cm in diameter AND a suspected or proven malignancy.
  • Chest CT scan available without and then with contrast
  • Eligible for VATS or RATS segmentectomy based on respiratory explorations

Exclusion criteria

  • Patient refusal to participate in the study
  • Allergic reactions to radiographic contrast agents
  • History of ipsilateral cardiothoracic surgery
  • Open segmentectomy (thoracotomy)
  • Histology different from that of NSCLC
  • Inability to provide the subject with informed information (difficulty understanding the subject, insufficient command of French, etc.)
  • Pregnant or breastfeeding women
  • Severe cognitive impairment and/or suspicion of lack of compliance or adherence, in the investigator's judgment

Trial design

50 participants in 1 patient group

Clinical stage IA lung lesions & malignancy
Description:
Patient with clinical stage IA lung lesions ≤ 2 cm in diameter AND a suspected or proven malignancy, cf eligibility criteria
Treatment:
Diagnostic Test: Thoraco-abdomino-pelvic CT scan without and with contrast injection.

Trial contacts and locations

1

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Central trial contact

Pierre-Emmanuel FALCOZ, MD, PhD; Chloé Moinet, Resident doctor

Data sourced from clinicaltrials.gov

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